BrainScope's FDA clearance expands, Kansas judge nixes tele-abortion ban, and more digital health news briefs

Also: ResApp files for CE Mark; researchers develop "pacemaker for the brain."
By Jonah Comstock

Clearance expands BrainScope's use cases. Bethesda, Maryland-based BrainScope has received FDA clearance for new labeling for its BrainScope One system, a wearable mobile device that helps medical professionals assess traumatic brain injury. Specifically, the new labelling expands the product's indications for use to include “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”. 

“This additional FDA labeling for our product, BrainScope One, recognizes the unique capabilities of our FDA-Cleared medical device with labeling distinctively and specifically for this particular disease state,” Michael Singer, CEO of BrainScope, said in a statement. “Years ago in working with our partner, the Department of Defense, we realized and learned from them the importance of multi-modality and objectivity. Combining a full range of concussion assessment capabilities on one handheld platform provides the clinician a timely and easy-to-use tool for collecting the objective data they need to facilitate their clinical diagnosis, right then and there, for this debilitating brain disease state.”


Kansas judge strikes down telemedicine abortion ban. A Kansas law that would have banned abortion via telemedicine was struck down last week when a judge ruled that it violates the state's constitution by singling out women seeking abortions. The case was brought by the New York-based Center for Reproductive Rights and Trust Women Wichita, an organization that operates a clinic where abortions, including telemedicine abortions, are performed. 

Kansas is only the latest battleground for the fight over abortions via telemedicine, which has been brought to the courts in both Iowa and Utah.


ResApp announces regulatory intentions. ResApp, a Brisbane, Australia-based company working on a smartphone app to assess respiratory health based on recordings of coughs and breathing, has filed for a CE Mark with the British Standards Institute and says it is planning a De Novo FDA submission within the quarter.

“The preparation and filing of the CE Mark Technical File for ResAppDx-EU, our flagship acute respiratory disease diagnostic tool, is an exciting moment for ResApp as it unlocks the last element required to commercialize our first product,” Tony Keating, CEO and managing director, said in a statement. “Europe represents a very attractive opportunity with a large portion of the continent’s 6 billion annual general practitioner visits related to respiratory disease. ResAppDx-EU will provide clinicians with the first rapid and accurate test for the most commonly-seen acute respiratory diseases. It has the potential to have far-reaching benefits for the healthcare system and we are working with a German private hospital network this European winter to quantify these benefits.”


Researchers develop "pacemaker for the brain". Researchers at The University of California, Berkeley have developed a brain implant that can monitor and produce electrical signals at the same time. The device, called the WAND (for wireless artifact-free neuromodulation device) could be useful in the treatment of Parkinson's Disease and seizure disorders such as epilepsy. 

"In order to deliver closed-loop stimulation-based therapies, which is a big goal for people treating Parkinson's and epilepsy and a variety of neurological disorders, it is very important to both perform neural recordings and stimulation simultaneously, which currently no single commercial device does," former UC Berkeley postdoctoral associate Samantha Santacruz, who is now an assistant professor at the University of Texas in Austin, said in a statement.